Unapproved analgesic sales stopped - Esgic with Codeine

FDA Consumer, April, 1990 by Dale Blumenthal

The federal government has told a drug manufacturer to stop selling a prescription painkiller because it is an unapproved new drug.

The analgesic, Esgic with Codeine, manufactured by Forest Pharmaceuticals, Inc., St. Louis, Mo., contains acetaminophen, caffeine, codeine, and butalbital (a barbiturate). Although FDA has approved each of these drugs individually, their combination in one product constitutes a new drug. Under FDA regulations, a new drug can't be marketed until the company submits-and FDA approves-a new drug application.

Forest Pharmaceuticals never sought or received approval for Esgic with Codeine, which the company began selling on April 15, 1987.

FDA immediately advised Forest to take Esgic with Codeine off the market. When Forest didn't comply, the agency considered requesting permission from federal court to seize the product, but delayed acting pending the outcome of a similar case involving the drug Fiorinal with Codeine No. 3. Manufactured by Sandoz Pharmaceuticals, Inc., East Hanover, N.J., Fiorinal with Codeine No. 3 contains the same ingredients as Esgic with Codeine except that it contains aspirin instead of acetaminophen.

In May 1988, the U.S. District Court for the Southern District of Ohio ruled that Fiorinal with Codeine No. 3 is an unapproved new drug. FDA then determined that Forest was still selling Esgic with Codeine and requested permission for seizure from the U.S. District Court for the Eastern District of Missouri. The court granted permission, and U.S. marshals seized approximately 750,000 capsules valued at over $20,000 on Aug. 1, 1988.

On July 10, 1989, the court ordered Forest to stop distributing Esgic with Codeine until the drug is approved by FDA. Forest appealed the court's decision on Oct. 26, 1989. As of this writing, Forest's appeal is being considered by the U.S. Court of Appeals for the 8th Circuit. Both the District Court and the Appeals Court have denied Forest's request to allow the drug to stay on the market during the appeal.